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Regulatory Compliance Manager – Lab Digitisation
EYManager in Regulatory Compliance leading Digital Laboratory initiatives with expertise in LIMS, ELN, and LES at EY. Driving digital solutions in regulated environments to enhance operational efficiency and compliance.
Tech Stack
Tools & technologiesPMP
About the role
Key responsibilities & impact- Lead and oversee Digital Lab initiatives, including LIMS, ELN, and LES implementations, upgrades, and optimizations in regulated laboratory environments
- Elicit, analyze, and document business requirements for LIMS implementations/enhancements, translating laboratory processes into functional specifications and user stories.
- Act as the bridge between business and technical teams, ensuring accurate mapping of lab workflows into system configurations and solution designs.
- Drive process optimization and standardization by identifying gaps, redundancies, and improvement opportunities across laboratory operations.
- Support system implementation and validation activities by defining test scenarios, coordinating UAT, ensuring traceability, and maintaining compliance with GxP, 21 CFR Part 11, and data integrity requirements.
- Facilitate stakeholder engagement and change management through workshops, training, documentation, and user support to drive adoption of LIMS solutions across labs.
- Partner with clients to understand laboratory operations and translate business and compliance requirements into integrated digital lab solutions and their respective configurations.
- Drive requirements gathering, system configuration, data migration, and integrations across lab systems, instruments, and enterprise platforms.
- Ensure data integrity, traceability, and compliance with GxP, 21 CFR Part 11, Annex 11, and internal SOPs.
- Guide clients through CSV / CSA / risk-based validation activities for digital lab systems.
- Support audits, inspections, and regulatory assessments related to laboratory systems.
- Identify opportunities for process harmonization, standardization, and digital enablement across laboratories.
- Lead, coach, and mentor Digital Lab consultants, validation analysts, and technical team members.
- Manage work allocation across LIMS, ELN, and LES engagements, ensuring quality delivery and adherence to timelines.
Requirements
What you’ll need- 8–12 years of experience in Digital Lab, LIMS, ELN, LES, or regulated laboratory systems
- Proven experience leading or supporting digital lab implementations, upgrades, or validation initiatives
- Experience working in regulated GxP environments, supporting audits and inspections
- Demonstrated experience managing teams, vendors, or complex stakeholders
- Strong documentation discipline and familiarity with controlled quality systems
- Ability to operate at a managerial level, balancing delivery and people leadership
- Ideally, you’ll also have Certifications such as Labware Configuration, Sample Manager developer, Computer System Validation (CSV/CSA), or Project Management Professional (PMP).
- Experience with global or multi-site digital laboratory implementations, upgrades, and inspection-readiness activities.
- Familiarity with emerging technologies in laboratory operations, including automation, analytics, and AI/ML-enabled solutions.
- Knowledge of data integrity principles, electronic records and signatures, and structured laboratory data management.
- Experience with industry-leading digital lab platforms such as LabWare, SampleManager, STARLIMS, Benchling, or equivalent systems.
Benefits
Comp & perks- Support, coaching and feedback from some of the most engaging colleagues around
- Opportunities to develop new skills and progress your career
- The freedom and flexibility to handle your role in a way that’s right for you
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
LIMSELNLESdigital lab implementationssystem configurationdata migrationvalidationprocess optimizationtest scenario definitionstakeholder engagement
Soft Skills
leadershipteam managementdocumentation disciplinechange managementcommunicationanalytical skillsproblem-solvingmentoringcollaborationclient partnership
Certifications
Labware ConfigurationSample Manager developerComputer System Validation (CSV/CSA)Project Management Professional (PMP)